BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N

    K Number: K061762 · Decision Aug 1, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    26
    Review Days
    40

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    Basic Information

    Device Name
    TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
    K Number
    K061762
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinal Health, Inc.
    Date Received
    June 22, 2006
    Decision Date
    August 1, 2006
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

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